(87 days)
K905464/A
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No
The summary describes a collection of standard medical devices for blood collection and transport, with no mention of AI or ML capabilities.
No
The device is described as a blood specimen collection and transport kit for In-Vitro Diagnostic Use only, and its purpose is for convenience during sampling, not for treating any condition or disease.
No
Explanation: The device is a blood collection kit used for specimen collection and transport, not for diagnosing diseases or conditions. Its intended use explicitly states "is for In-Vitro Diagnostic Use only," referring to the subsequent use of the collected blood, not the kit itself as a diagnostic tool.
No
The device description clearly states it is an "assembly of medical products within a pouch," including physical components like blood collection tubes and needles. This indicates it is a hardware-based medical device kit, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states that the kit "is for In-Vitro Diagnostic Use only."
- Purpose of the Kit: The kit is designed for "venous blood specimen collection and transport," which are essential steps in preparing a sample for in-vitro diagnostic testing.
- Components for Specimen Collection: The description mentions the kit includes "blood collection tubes and needles for the sampling procedure," which are components directly used in obtaining a biological specimen for analysis outside of the body.
While the device itself doesn't perform the diagnostic test, it provides the necessary tools and materials for collecting and transporting the specimen that will be used for an in-vitro diagnostic test. This makes it an IVD accessory or component.
N/A
Intended Use / Indications for Use
The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.
Product codes
EP 27
Device Description
The Customed Blood Collection Kits are an assembly of medical products within a pouch. The medical products are disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the kit are commonly used for blood specimen collection and Customed is not claiming or causing new uses through the intended use of the kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professions
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
No clinical evaluations were completed.
Key Metrics
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Predicate Device(s)
K905464/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
510(K) Summary Customed Blood Collection Kit
EP 27
Submitter Information
Customed Calle Igualdad #7 Prjardo, PR 00738 Tel: (809) 860-2500
510(K) Summary Prepared By:
Carolann Kotula mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 Tel: (516) 482-9001
| Date 510(K) Summary Prepared: | August 15, 1996 |
|---|---|
| Trade or Proprietary Name: | Customed Blood Collection Kit |
| Common Name: | Venous Blood Specimen Collection Kit |
| Classification Name: | Blood Specimen Collection devices, 21 CFR 862.1675 |
Identification of Legally Marketed Device to which the Submitter Claims Equivalence:
The Customed Blood Extraction kit is substantially equivalent in intended use, and kit contents as various blood collection kits legally marketed by Angiosystems, Inc. under K905464/A.
Description of the Subjected Devices:
The Customed Blood Collection Kits are an assembly of medical products within a pouch. The medical products are disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the kit are commonly used for blood specimen collection and Customed is not claiming or causing new uses through the intended use of the kit.
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510(K) Summary Customed Blood Collection Kit
Intended Use of the Subject Devices
The Customed Blood Collection Kits are intended to be used by Healthcare professions for venous blood specimen collection and transport, and is for In-Vitro Diagnostic Use only. The kit is used to prepare the skin for sampling, provide blood collection tubes and needles for the sampling procedure, and to cover the sampling site when the procedure is complete.
Technical Characteristics of the Subject Device
The technological characteristics of the Customed Blood Collection kit and the predicate device are substantially eqivalent as supported by the comparison of similar significant features, components, and intended use.
No clinical evaluations were completed.